10 Steps to Perfect SOPs: FDA Acceptable SOPs made Easy

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Description:

This seminar will walk the attendee through 10 critical steps in the development of perfect Standard Operating Procedures. Step-by-step instructions will be provided, with case studies to emphasize the common mistakes and potential solutions.

This seminar will help you evaluate your current SOPs for the presence of most common issues identified by FDA during audits. You will get practical tips and tested strategies for creating, revising, updating, training, and documenting SOP processes at your organization. The case studies will highlight the key concepts, alternate methods, and least-burdensome approach to compliance with FDA regulations.

Formal and written Standard Operating Procedures (SOPs) are keystones of good operations. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This seminar will provide step by step instructions to create SOPs for FDA-regulated organizations. The author will discuss case studies and examples to highlight the common errors and potential solutions. Additionally, the logistics of creating, maintaining, scope, training and documentation will be reviewed. Pros and Cons of paper and electronic SOPs will also be discussed. This seminar contains a collection of practical tips from the trainer’s extensive FDA audit experience.

Areas to be Covered:

Essential elements of an SOP
Process mapping techniques to define the contents of an SOP
Role of personnel in creating SOPs
SOP revisions, updates, creation, retirement and documentation
Categorization of SOPs
Assessment of compliance techniques
Training practices for FDA compliance
Access and access control to SOPs

Who will Benefit:

QA/QC/compliance/regulatory professionals
Senior management executives (CEO, COO, CFO, etc)
Manufacturing managers, supervisors and personnel
Clinical and preclinical laboratory managers
Clinical trial specialists
Project managers
People investing in FDA-regulated product development projects

Dr. Mukesh Kumar

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance